Method of fabricating customized patient-specific bone cutting blocks

ABSTRACT

A number of orthopedic surgical instruments are also disclosed. A method, apparatus, and system for fabricating such instruments are also disclosed.

This application claims priority under 35 U.S.C. §119(e) to U.S.Provisional Patent Application Ser. No. 61/308,180, entitled “Method ofFabricating Customized Patient-Specific Bone Cutting Blocks,” which wasfiled on Feb. 25, 2010 by Jose Guzman et al., the entirety of which isincorporated by reference.

CROSS-REFERENCE TO RELATED U.S. PATENT APPLICATIONS

Cross-reference is made to co-pending U.S. Utility patent applicationSer. Nos. 12/240,985; 12/240,990; 12/240,988; 12/240,992; 12/240,994;12/240,996; 12/240,997; 12/240,998; 12/241,006; 12/241,002; 12/241,001;and 12/240,999. Each of these applications was filed on Sep. 29, 2008,and is assigned to the same assignee as the present application. Each ofthese applications is hereby incorporated by reference.

TECHNICAL FIELD

The present disclosure relates generally to customized patient-specificorthopaedic surgical instruments and to methods, devices, and systemsfor fabricating and positioning such instruments.

BACKGROUND

Joint arthroplasty is a well-known surgical procedure by which adiseased and/or damaged natural joint is replaced by a prosthetic joint.A typical knee prosthesis includes a tibial tray, a femoral component, apolymer insert or bearing positioned between the tibial tray and thefemoral component, and, in some cases, a polymer patella button. Tofacilitate the replacement of the natural joint with the kneeprosthesis, orthopaedic surgeons use a variety of orthopaedic surgicalinstruments such as, for example, cutting blocks, drill guides, millingguides, and other surgical instruments. Typically, the orthopaedicsurgical instruments are generic with respect to the patient such thatthe same orthopaedic surgical instrument may be used on a number ofdifferent patients during similar orthopaedic surgical procedures.

SUMMARY

According to one aspect, a method for a vendor to create a customizedpatient-specific orthopaedic instrument for a patient of a healthcarefacility that is external to the vendor includes receiving, from thehealthcare facility external to the vendor, an instrument request thatincludes data relevant to a bone of the patient. In response toreceiving the instrument request, a surgical design plan is created thatis customized for the patient per data of the instrument request. Thesurgical design plan includes a preoperatively planned size of at leastone bone chip produced as a result of a surgical resection of the boneof the patient consistent with the surgical design plan. The surgicaldesign plan is then sent to the healthcare facility.

A manufacturing machine located at the vendor may be operated tofabricate the customized patient-specific orthopaedic instrument perdata of the surgical design plan, with the fabricated customizedpatient-specific orthopaedic instrument then being sent to thehealthcare facility.

The surgical design plan may be transmitted to the healthcare facilityvia a network. In some embodiments, the surgical design plan is mailedto the healthcare facility.

The data relevant to the bone of the patient may include one or moremedical images of the bone of the patient, and the surgical design planmay be created based upon the one or more medical images of the bone ofthe patient.

The data relevant to the bone of the patient may include one or moremedical images of the femur of the patient. The surgical design plan mayinclude a preoperatively planned size of a distal medial bone chipproduced as a result of a surgical resection of the distal medialportion of the patient's distal femur consistent with the surgicaldesign plan. The surgical design plan may also include a preoperativelyplanned size of a distal lateral bone chip produced as a result of asurgical resection of the distal lateral portion of the patient's distalfemur consistent with the surgical design plan.

The surgical design plan may also include a preoperatively planned sizeof a posterior medial bone chip produced as a result of a surgicalresection of the posterior medial portion of the patient's distal femurconsistent with the surgical design plan, and a posterior lateral bonechip produced as a result of a surgical resection of the posteriorlateral portion of the patient's distal femur consistent with thesurgical design plan.

The data relevant to the bone of the patient may include one or moremedical images of the tibia of the patient. The surgical design plan mayinclude a preoperatively planned size of a bone chip produced as aresult of a surgical resection of the proximal medial portion and theproximal lateral portion of the patient's proximal tibia consistent withthe surgical design plan.

The surgical design plan may include a visual indication of the bonechip produced as a result of the surgical resection of the bone of thepatient consistent with the surgical design plan.

According to another aspect, a method of performing an orthopaedicsurgical procedure on a bone of a patient at a healthcare facilityincludes making a cut in the bone of the patient at a location indicatedin a surgical design plan obtained from a vendor that is external to thehealthcare facility that has been customized for the patient per datarelevant to a bone of the patient. The surgical design plan may includea preoperatively planned size of a bone chip produced as a result of thecut. The actual size of the bone chip produced as a result of the cutmay then be measured, with the measured actual size of the bone chipthen being compared to the preoperatively planned size of the bone chipof the surgical design plan.

The cut may be made with a customized patient-specific orthopaediccutting block fabricated per data of the surgical design plan.

The cut in the bone of the patient may be made at a location indicatedin a surgical design plan obtained from a vendor that is external to thehealthcare facility that has been customized for the patient per one ormore medical images of the bone of the patient.

The surgical design plan may include a preoperatively planned size of adistal medial bone chip produced as a result of a surgical resection ofthe distal medial portion of the patient's distal femur consistent withthe surgical design plan. The surgical design plan may also include apreoperatively planned size of a distal lateral bone chip produced as aresult of a surgical resection of the distal lateral portion of thepatient's distal femur consistent with the surgical design plan.

The surgical design plan may also include a preoperatively planned sizeof a posterior medial bone chip produced as a result of a surgicalresection of the posterior medial portion of the patient's distal femurconsistent with the surgical design plan, and a posterior lateral bonechip produced as a result of a surgical resection of the posteriorlateral portion of the patient's distal femur consistent with thesurgical design plan.

The surgical design plan may include a preoperatively planned size of abone chip produced as a result of a surgical resection of the proximalmedial portion and the proximal lateral portion of the patient'sproximal tibia consistent with the surgical design plan.

The actual size of the bone chip may be measured with calipers.

According to another aspect, a method of performing an orthopaedicsurgical procedure on a bone of a patient includes preoperativelyplanning a size of a bone chip to be produced by resecting the bone ofthe patient at a predetermined location. A cut is made in the bone ofthe patient at the predetermined location thereby producing a bone chip.The actual size of the bone chip produced as a result of the cut ismeasured and compared to the preoperatively planned size of the bonechip.

The bone of the patient is re-cut if the measured actual size of thebone chip is smaller than the preoperatively planned size of the bonechip.

The actual size of the bone chip may be measured with calipers.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the following figures,in which:

FIG. 1 is a simplified flow diagram of an algorithm for designing andfabricating a customized patient-specific orthopaedic surgicalinstrument;

FIG. 2 is a simplified flow diagram of a method for generating a modelof a patient-specific orthopaedic instrument;

FIG. 3 is a simplified flow diagram of a method for scaling a referencecontour;

FIGS. 4-6 are three-dimensional model's of a patient's tibia;

FIG. 7-9 are three-dimensional models of a patient's femur;

FIG. 10 is an anterior elevation an embodiment of a customizedpatient-specific orthopaedic surgical instrument;

FIG. 11 is a top plan view of the customized patient-specificorthopaedic surgical instrument of FIG. 10;

FIG. 12 is side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 10;

FIG. 13 is an anterior elevation view of another embodiment of acustomized patient-specific orthopaedic surgical instrument;

FIG. 14 is a top plan view of the customized patient-specificorthopaedic surgical instrument of FIG. 13;

FIG. 15 is side elevation view of the customized patient-specificorthopaedic surgical instrument of FIG. 13; and

FIG. 16 is a diagrammatic view of showing a visual representation of asurgical design plan and a pair of customized patient-specificorthopaedic surgical instruments based thereon.

DETAILED DESCRIPTION OF THE DRAWINGS

While the concepts of the present disclosure are susceptible to variousmodifications and alternative forms, specific exemplary embodimentsthereof have been shown by way of example in the drawings and willherein be described in detail. It should be understood, however, thatthere is no intent to limit the concepts of the present disclosure tothe particular forms disclosed, but on the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the appended claims.

Terms representing anatomical references, such as anterior, posterior,medial, lateral, superior, inferior, etcetera, may be used throughoutthis disclosure in reference to the orthopaedic implants and instrumentsdescribed herein, along with a patient's natural anatomy. Such termshave well-understood meanings in both the study of anatomy and the fieldof orthopaedics. Use of such anatomical reference terms in thespecification and claims is intended to be consistent with theirwell-understood meanings unless noted otherwise.

Referring to FIG. 1, an algorithm 10 for fabricating a customizedpatient-specific orthopaedic surgical instrument is illustrated. What ismeant herein by the term “customized patient-specific orthopaedicsurgical instrument” is a surgical tool for use by a surgeon inperforming an orthopaedic surgical procedure that is intended, andconfigured, for use on a particular patient. As such, it should beappreciated that, as used herein, the term “customized patient-specificorthopaedic surgical instrument” is distinct from standard, non-patientspecific orthopaedic surgical instruments that are intended for use on avariety of different patients. Additionally, it should be appreciatedthat, as used herein, the term “customized patient-specific orthopaedicsurgical instrument” is distinct from orthopaedic prostheses, whetherpatient-specific or generic, which are surgically implanted in the bodyof the patient. Rather, customized patient-specific orthopaedic surgicalinstruments are used by an orthopaedic surgeon to assist in theimplantation of orthopaedic prostheses.

In some embodiments, the customized patient-specific orthopaedicsurgical instrument may be customized to the particular patient based onthe location at which the instrument is to be coupled to one or morebones of the patient, such as the femur and/or tibia. For example, insome embodiments, the customized patient-specific orthopaedic surgicalinstrument may include a bone-contacting or facing surface having anegative contour that matches or substantially matches the contour of aportion of the relevant bone of the patient. As such, the customizedpatient-specific orthopaedic surgical instrument is configured to becoupled to the bone of a patient in a unique location and position withrespect to the patient's bone. That is, the negative contour of thebone-contacting surface is configured to receive the matching contoursurface of the portion of the patient's bone. As such, the orthopaedicsurgeon's guesswork and/or intra-operative decision-making with respectto the placement of the orthopaedic surgical instrument are reduced. Forexample, the orthopaedic surgeon may not be required to locate landmarksof the patient's bone to facilitate the placement of the orthopaedicsurgical instrument, which typically requires some amount of estimationon part of the surgeon. Rather, the orthopaedic surgeon may simplycouple the customized patient-specific orthopaedic surgical instrumenton the bone or bones of the patient in the unique location. When socoupled, the cutting plane, drilling holes, milling holes, and/or otherguides are defined in the proper location relative to the bone andintended orthopaedic prosthesis. The customized patient-specificorthopaedic surgical instrument may be embodied as any type oforthopaedic surgical instrument such as, for example, a bone-cuttingblock, a drilling guide, a milling guide, or other type of orthopaedicsurgical instrument configured to be coupled to a bone of a patient.

As shown in FIG. 1, the algorithm 10 includes process steps 12 and 14,in which an orthopaedic surgeon performs pre-operative planning of theorthopaedic surgical procedure to be performed on a patient. The processsteps 12 and 14 may be performed in any order or contemporaneously witheach other. In process step 12, a number of medical images of therelevant bony anatomy or joint of the patient are generated. To do so,the orthopaedic surgeon or other healthcare provider may operate animaging system to generate the medical images. The medical images may beembodied as any number and type of medical images capable of being usedto generate a three-dimensional rendered model of the patient's bonyanatomy or relevant joint. For example, the medical images may beembodied as any number of computed tomography (CT) images, magneticresonance imaging (MRI) images, or other three-dimensional medicalimages. Additionally or alternatively, as discussed in more detail belowin regard to process step 18, the medical images may be embodied as anumber of X-ray images or other two-dimensional images from which athree-dimensional rendered model of the patient's relevant bony anatomymay be generated. Additionally, in some embodiments, the medical imagemay be enhanced with a contrast agent designed to highlight thecartilage surface of the patient's knee joint.

In process step 14, the orthopaedic surgeon may determine any additionalpre-operative constraint data. The constraint data may be based on theorthopaedic surgeon's preferences, preferences of the patient,anatomical aspects of the patient, guidelines established by thehealthcare facility, or the like. For example, the constraint data mayinclude the orthopaedic surgeon's preference for a metal-on-metalinterface, amount of inclination for implantation, the thickness of thebone to resect, size range of the orthopaedic implant, and/or the like.In some embodiments, the orthopaedic surgeon's preferences are saved asa surgeon's profile, which may used as a default constraint values forfurther surgical plans.

In process step 16, the medical images and the constraint data, if any,are transmitted or otherwise provided to an orthopaedic surgicalinstrument vendor or manufacturer. The medical images and the constraintdata may be transmitted to the vendor via electronic means such as anetwork or the like. After the vendor has received the medical imagesand the constraint data, the vendor processes the images in step 18. Theorthopaedic surgical instrument vendor or manufacturer process themedical images to facilitate the determination of the bone cuttingplanes, implant sizing, and fabrication of the customizedpatient-specific orthopaedic surgical instrument as discussed in moredetail below. For example, in process step 20 the vendor may convert orotherwise generate three-dimensional images from the medical images. Forexample, in embodiments wherein the medical images are embodied as anumber of two-dimensional images, the vendor may use a suitable computeralgorithm to generate one or more three-dimensional images form thenumber of two-dimensional images. Additionally, in some embodiments, themedical images may be generated based on an established standard such asthe Digital Imaging and Communications in Medicine (DICOM) standard. Insuch embodiments, an edge-detection, thresholding, watershead, orshape-matching algorithm may be used to convert or reconstruct images toa format acceptable in a computer aided design application or otherimage processing application. Further, in some embodiments, an algorithmmay be used to account for tissue such as cartilage not discernable inthe generated medical images. In such embodiments, any three-dimensionalmodel of the patient-specific instrument (see, e.g., process step 26below) may be modified according to such algorithm to increase the fitand function of the instrument.

In process step 22, the vendor may process the medical images, and/orthe converted/reconstructed images from process step 20, to determine anumber of aspects related to the bony anatomy of the patient such as theanatomical axis of the patient's bones, the mechanical axis of thepatient's bone, other axes and various landmarks, and/or other aspectsof the patient's bony anatomy. To do so, the vendor may use any suitablealgorithm to process the images.

In process step 24, the cutting planes of the patient's bone aredetermined. The planned cutting planes are determined based on the type,size, and position of the orthopaedic prosthesis to be used during theorthopaedic surgical procedure, on the process images such as specificlandmarks identified in the images, and on the constraint data suppliedby the orthopaedic surgeon in process steps 14 and 16. The type and/orsize of the orthopaedic prosthesis may be determined based on thepatient's anatomy and the constraint data. For example, the constraintdata may dictate the type, make, model, size, or other characteristic ofthe orthopaedic prosthesis. The selection of the orthopaedic prosthesismay also be modified based on the medical images such that anorthopaedic prosthesis that is usable with the bony anatomy of thepatient and that matches the constraint data or preferences of theorthopaedic surgeon is selected.

In addition to the type and size of the orthopaedic prosthesis, theplanned location and position of the orthopaedic prosthesis relative tothe patient's bony anatomy is determined. To do so, a digital templateof the selected orthopaedic prosthesis may be overlaid onto one or moreof the processed medical images. The vendor may use any suitablealgorithm to determine a recommended location and orientation of theorthopaedic prosthesis (i.e., the digital template) with respect to thepatient's bone based on the processed medical images (e.g., landmarks ofthe patient's bone defined in the images) and/or the constraint data.Additionally, any one or more other aspects of the patient's bonyanatomy may be used to determine the proper positioning of the digitaltemplate.

In some embodiments, the digital template along with surgical alignmentparameters may be presented to the orthopaedic surgeon for approval. Theapproval document may include the implant's rotation with respect tobony landmarks such as the femoral epicondyle, posterior condyles,sulcus groove (Whiteside's line), and the mechanical axis as defined bythe hip, knee, and/or ankle centers.

The planned cutting planes for the patient's bone(s) may then bedetermined based on the determined size, location, and orientation ofthe orthopaedic prosthesis. In addition, other aspects of the patient'sbony anatomy, as determined in process step 22, may be used to determineor adjust the planned cutting planes. For example, the determinedmechanical axis, landmarks, and/or other determined aspects of therelevant bones of the patient may be used to determine the plannedcutting planes.

Along with determining the planned cutting planes, the planned sizes ofthe of the resultant bone chips are also determined. In particular, thepreoperative surgical design plan created by the vendor includes adetermination of the size of the bone chips that will be created when asurgeon executes the surgical design plan and resects the patient's bonealong the planned cutting planes. In other words, a part of the surgicaldesign plan is to create a model that includes the individual sizes ofthe “bone scrap” created by proper execution of the surgical designplan. As will be discussed below in greater detail, inclusion of thesize of the bone chips created by proper execution of the surgicaldesign plan provides a relatively easy way for the surgeon to confirmconformance with the surgical design plan. For example, if the surgicaldesign plan preoperatively informs the surgeon that a proper resectionof the distal lateral portion of the patient's femur along the plannedcutting plane results in a distal lateral bone chip that is 11.0 mmthick, the surgeon can quickly and easily confirm his conformance withthe surgical design plan by simply measuring the thickness of the distallateral bone chip with, for example, a set of calipers after it has beenresected from the patient's femur.

In the case of creation of a customized patient-specific femoral cuttingblock, the surgical design plan may include a model of the planned sizeof a distal medial bone chip produced as a result of a surgicalresection of the distal medial portion of the patient's distal femur(DMF) consistent with the surgical design plan. It may also include theplanned size of a distal lateral bone chip produced as a result of asurgical resection of the distal lateral portion of the patient's distalfemur (DLF) consistent with the surgical design plan. The surgicaldesign plan for use with a customized patient-specific femoral cuttingblock may also include the size of a posterior medial bone chip producedas a result of a surgical resection of the posterior medial portion ofthe patient's distal femur (PMF) consistent with the surgical designplan, and a posterior lateral bone chip produced as a result of asurgical resection of the posterior lateral portion of the patient'sdistal femur (PLF) consistent with the surgical design plan.

In the case of creation of a customized patient-specific tibial cuttingblock, the surgical design plan may include a model of the planned sizeof the bone chip (or chips) produced as a result of a surgical resectionof the proximal medial portion (MT) and the proximal lateral portion(LT) of the patient's proximal tibia consistent with the surgical designplan.

In process step 26, a model of the customized patient-specificorthopaedic surgical instrument is generated. In some embodiments, themodel is embodied as a three-dimensional rendering of the customizedpatient-specific orthopaedic surgical instrument. In other embodiments,the model may be embodied as a mock-up or fast prototype of thecustomized patient-specific orthopaedic surgical instrument. Theparticular type of orthopaedic surgical instrument to be modeled andfabricated may be determined based on the orthopaedic surgical procedureto be performed, the constraint data, and/or the type of orthopaedicprosthesis to be implanted in the patient. As such, the customizedpatient-specific orthopaedic surgical instrument may be embodied as anytype of orthopaedic surgical instrument for use in the performance of anorthopaedic surgical procedure. For example, the orthopaedic surgicalinstrument may be embodied as a bone-cutting block, a drilling guide, amilling guide, and/or any other type of orthopaedic surgical tool orinstrument.

The particular shape of the customized patient-specific orthopaedicsurgical instrument is determined based on the planned location of theorthopaedic surgical instrument relative to the patient's bony anatomy.The location of the customized patient-specific orthopaedic surgicalinstrument with respect to the patient's bony anatomy is determinedbased on the type and determined location of the orthopaedic prosthesisto be used during the orthopaedic surgical procedure. That is, theplanned location of the customized patient-specific orthopaedic surgicalinstrument relative to the patient's bony anatomy may be selected basedon, in part, the planned cutting planes of the patient's bone(s) asdetermined in step 24. For example, in embodiments wherein thecustomized patient-specific orthopaedic surgical instrument is embodiedas a bone-cutting block, the location of the orthopaedic surgicalinstrument is selected such that the cutting guide of the bone-cuttingblock matches one or more of the planned cutting planes determined inprocess step 24. Additionally, the planned location of the orthopaedicsurgical instrument may be based on the identified landmarks of thepatient's bone identified in process step 22.

In some embodiments, the particular shape or configuration of thecustomized patient-specific orthopaedic surgical instrument may bedetermined based on the planned location of the instrument relative tothe patient's bony anatomy. That is, the customized patient-specificorthopaedic surgical instrument may include a bone-contacting surfacehaving a negative contour that matches the contour of a portion of thebony anatomy of the patient such that the orthopaedic surgicalinstrument may be coupled to the bony anatomy of the patient in a uniquelocation, which corresponds to the pre-planned location for theinstrument. When the orthopaedic surgical instrument is coupled to thepatient's bony anatomy in the unique location, one or more guides (e.g.,cutting or drilling guide) of the orthopaedic surgical instrument may bealigned to one or more of the bone cutting plane(s) as discussed above.

One illustrative embodiment of a method 40 for generating a model, suchas a computer model, of a patient-specific orthopaedic instrument isillustrated in FIGS. 2 through 9. The method 40 begins with a step 42 inwhich a cartilage thickness value is determined. The cartilage thicknessvalue is indicative of the average thickness of the cartilage of thepatient's bone. As such, in one embodiment, the cartilage thicknessvalue is equal to the average thickness of cartilage for an individualhaving similar characteristics as the patient. For example, thecartilage thickness value may be equal to the average thickness value ofindividuals of the same gender as the patient, the same age as thepatient, having the same activity level of the patient, and/or the like.In other embodiments, the cartilage thickness value is determined basedon one or more medical images of the patient's bone, such as thoseimages transmitted in process step 16.

In step 44, a reference contour of the patient's relevant bone isdetermined. The reference contour is based on the surface contour of athree-dimensional model of the patient's relevant bone, such as thethree-dimensional model generated in step 20. Initially the referencecontour is identical to a region (i.e. the region of interest such asthe distal end of the patient's femur or the proximal end of thepatient's tibia) of the patient's bone. That is, in some embodiments,the reference contour is juxtaposed on the surface contour of the regionof the patient's bone.

Subsequently, in step 46, the reference contour is scaled to compensatefor the cartilage thickness value determined in step 42. To do so, inone embodiment, the scale of the reference contour is increased based onthe cartilage thickness value. For example, the scale of the referencecontour may be increased by an amount equal to or determined from thecartilage thickness value. However, in other embodiments, the referencecontour may be scaled using other techniques designed to scale thereference contour to a size at which the reference contour iscompensated for the thickness of the cartilage on the patient's bone.

For example, in one particular embodiment, the reference contour isscaled by increasing the distance between a fixed reference point and apoint lying on, and defining in part, the reference contour. To do so,in one embodiment, a method 60 for scaling a reference contour asillustrated in FIG. 3 may be used. The method 60 begins with step 62 inwhich a medial/lateral line segment is established on thethree-dimensional model of the patient's relevant bone. Themedial/lateral line segment is defined or otherwise selected so as toextend from a point lying on the medial surface of the patient's bone toa point lying on lateral surface of the patient's bone. The medialsurface point and the lateral surface point may be selected so as todefine the substantially maximum local medial/lateral width of thepatient's bone in some embodiments.

In step 64, an anterior/posterior line segment is established on thethree-dimensional model of the patient's relevant bone. Theanterior/posterior line segment is defined or otherwise selected so asto extend from a point lying on the anterior surface of the patient'sbone to a point lying on posterior surface of the patient's bone. Theanterior surface point and the posterior surface point may be selectedso as to define the substantially maximum local anterior/posterior widthof the patient's bone in some embodiments.

The reference point from which the reference contour will be scaled isdefined in step 66 as the intersection point of the medial/lateral linesegment and anterior/posterior line segment. As such, it should beappreciated that the medial surface point, the lateral surface point,the anterior surface point, and the posterior surface point lie on thesame plane. After the reference point is initially established in step66, the reference point is moved or otherwise translated toward an endof the patient's bone. For example, in embodiments wherein the patient'sbone is embodied as a femur, the reference point is moved inferiorlytoward the distal end of the patient's femur. Conversely, in embodimentswhen the patient's bone is embodied as a tibia, the reference point ismoved superiorly toward the proximal end of the patient's tibia. In oneembodiment, the reference point is moved a distance equal to about halfthe length of the anterior/posterior line segment as determined in step64. However, in other embodiments, the reference point may be movedother distances sufficient to compensate the reference contour forthickness of the cartilage present on the patient's bone.

Once the location of the reference point has been determined in step 68,the distance between the reference point and each point lying on, anddefining in part, the reference contour is increased in step 70. To doso, in one particular embodiment, each point of the reference contour ismoved a distance away from the reference point based on a percentagevalue of the original distance defined between the reference point andthe particular point on the reference contour. For example, in oneembodiment, each point lying on, and defining in part, the referencecontour is moved away from the reference point in by a distance equal toa percentage value of the original distance between the reference pointand the particular point. In one embodiment, the percentage value is inthe range of about 5 percent to about thirty percent. In one particularembodiment, the percentage value is about ten percent.

Referring now to FIGS. 4-9, in another embodiment, the reference contouris scaled by manually selecting a local “high” point on the surfacecontour of the three-dimensional image of the patient's bone. Forexample, in embodiments wherein the relevant patient's bone is embodiedas a tibia as illustrated in FIGS. 4-6, the reference point 90 isinitially located on the tibial plateau high point of the tibial model92. Either side of the tibial plateau may be used. Once the referencepoint 90 is initially established on the tibial plateau high point, thereference point 90 is translated to the approximate center of theplateau as illustrated in FIG. 5 such that the Z-axis defining thereference point is parallel to the mechanical axis of the tibial model92. Subsequently, as illustrated in FIG. 6, the reference point is movedin the distal direction by a predetermined amount. In one particularembodiment, the reference point is moved is the distal direction byabout 20 millimeters, but other distances may be used in otherembodiments. For example, the distance over which the reference point ismoved may be based on the cartilage thickness value in some embodiments.

Conversely, in embodiments wherein the relevant patient's bone isembodied as a femur as illustrated in FIGS. 7-9, the reference point 90is initially located on the most distal point of the distal end of thefemoral model 94. Either condyle of the femoral model 94 may be used invarious embodiments. Once the reference point 90 is initiallyestablished on the most distal point, the reference point 90 istranslated to the approximate center of the distal end of the femoralmodel 94 as illustrated in FIG. 8 such that the Z-axis defining thereference point 90 is parallel to the mechanical axis of the femoralmodel 92. The anterior-posterior width 96 of the distal end of thefemoral model 94 is also determined. Subsequently, as illustrated inFIG. 9, the reference point is moved or otherwise translated in theproximal or superior direction by a distance 98. In one particularembodiment, the reference point is moved in the distal or superiordirection by a distance 98 equal to about half the distance 96. As such,it should be appreciated that one of a number of different techniquesmay be used to define the location of the reference point based on, forexample, the type of bone.

Referring now back to FIG. 2, once the reference contour has been scaledin step 46, the medial/lateral sides of the reference contour areadjusted in step 48. To do so, in one embodiment, the distance betweenthe reference point and each point lying on, and defining in part, themedial side and lateral side of the reference contour is decreased. Forexample, in some embodiments, the distance between the reference pointand the points on the medial and lateral sides of the scaled referencecontour are decreased to the original distance between such points. Assuch, it should be appreciated that the reference contour is offset orotherwise enlarged with respect to the anterior side of the patient'sbone and substantially matches or is otherwise not scaled with respectto the medial and lateral sides of the patient's bone.

The reference contour may also be adjusted in step 48 for areas of thepatient's bone having a reduced thickness of cartilage. Such areas ofreduced cartilage thickness may be determined based on the existence ofbone-on-bone contact as identified in a medical image, simulation, orthe like. Additionally, information indicative of such areas may beprovided by the orthopaedic surgeon based on his/her expertise. If oneor more areas of reduced cartilage thickness are identified, thereference contour corresponding to such areas of the patient's bone isreduced (i.e., scaled back or down).

Additionally, in some embodiments, one or more osteophytes on thepatient's bone may be identified; and the reference contour may becompensated for such presence of the osteophytes. By compensating forsuch osteophytes, the reference contour more closely matches the surfacecontour of the patient's bone. Further, in some embodiments, a distalend (in embodiments wherein the patient's bone is embodied as a tibia)or a proximal end (in embodiments wherein the patient's bone is embodiedas a femur) of the reference contour may be adjusted to increase theconformity of the reference contour to the surface contour of the bone.For example, in embodiments wherein the patient's bone is a femur, thesuperior end of the scaled reference contour may be reduced or otherwisemoved closer to the surface contour of the patient's femur in the regionlocated superiorly to a cartilage demarcation line defined on thepatient's femur. Conversely, in embodiments wherein the patient's boneis embodied as a tibia, an inferior end of the scaled reference contourmay be reduced or otherwise moved closer to the surface contour of thepatient's tibia in the region located inferiorly to a cartilagedemarcation line of the patient's tibia. As such, it should beappreciated that the scaled reference contour is initially enlarged tocompensate for the thickness of the patient's cartilage on the patient'sbone. Portions of the scaled reference contour are then reduced orotherwise moved back to original positions and/or toward the referencepoint in those areas where cartilage is lacking, reduced, or otherwisenot present.

Once the reference contour has been scaled and adjusted in steps 46 and48, the position of the cutting guide is defined in step 50. Inparticular, the position of the cutting guide is defined based on anangle defined between a mechanical axis of the patient's femur and amechanical axis of the patient's tibia. The angle may be determined byestablishing a line segment or ray originating from the proximal end ofthe patient's femur to the distal end of the patient's femur anddefining a second line segment or ray extending from the patient's anklethrough the proximal end of the patient's tibia. The angle defined bythese two line segments/rays is equal to the angle defined between themechanical axis of the patient's femur and tibia. The position of thebone cutting guide is then determined based on the angle between themechanical axes of the patient's femur and tibia. It should beappreciated that the position of the cutting guide defines the positionand orientation of the cutting plane of the customized patient-specificcutting block. Subsequently, in step 52, a negative contour of thecustomized patient-specific cutting block is defined based on the scaledand adjusted reference contour and the angle defined between themechanical axis of the femur and tibia.

Referring back to FIG. 1, after the model of the customizedpatient-specific orthopaedic surgical instrument has been generated inprocess step 26, the model is validated in process step 28. The modelmay be validated by, for example, analyzing the rendered model whilecoupled to the three-dimensional model of the patient's anatomy toverify the correlation of cutting guides and planes, drilling guides andplanned drill points, and/or the like. Additionally, the model may bevalidated by transmitting or otherwise providing the model generated instep 26 to the orthopaedic surgeon for review. For example, inembodiments wherein the model is a three-dimensional rendered model, themodel along with the three-dimensional images of the patient's relevantbone(s) may be transmitted to the surgeon for review. In embodimentswherein the model is a physical prototype, the model may be shipped tothe orthopaedic surgeon for validation.

After the model has been validated in process step 28, the customizedpatient-specific orthopaedic surgical instrument is fabricated inprocess step 30. The customized patient-specific orthopaedic surgicalinstrument may be fabricated using any suitable fabrication device andmethod. Additionally, the customized patient-specific orthopaedicinstrument may be formed from any suitable material such as a metallicmaterial, a plastic material, or combination thereof depending on, forexample, the intended use of the instrument. In fabricating theinstrument, customized patient-specific indicia may be applied to theinstrument. For example, as noted above, the size of the bone chipsproduced by proper use of the instrument may be preoperativelydetermined to facilitate the surgeon's conformance to the surgical plan.Indicia indicative of the size of the bone chips may be applied (e.g.,etched, painted, engraved, etcetera) to the outer surface of theinstrument in an area near the cutting slot used to create the bonechip. Such indicia makes it easy for the surgeon to quickly ascertainthe preoperatively determined size of the bone chip without having torefer to a document or display monitor.

The fabricated customized patient-specific orthopaedic instrument issubsequently shipped or otherwise provided to the orthopaedic surgeon.The surgeon performs the orthopaedic surgical procedure in process step32 using the customized patient-specific orthopaedic surgicalinstrument. As discussed above, because the orthopaedic surgeon does notneed to determine the proper location of the orthopaedic surgicalinstrument intra-operatively, which typically requires some amount ofestimation on part of the surgeon, the guesswork and/or intra-operativedecision-making on part of the orthopaedic surgeon is reduced.

Referring now to FIGS. 10-12, in one embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as afemoral cutting block 200. The cutting block 200 is configured to becoupled to a femur of a patient. The cutting block 200 includes a body202 configured to be coupled to the anterior side of the patient's femurand two arms or tabs 204, 206, which extend away from the body 202 in aposteriorly direction. The tabs 204, 206 are configured to wrap around adistal end of the femur as discussed in more detail below. Each of thetabs 204, 206 includes an inwardly-curving or otherwise superiorlyextending lip 208, 210, respectively, which references the posteriorcondyles of the femur. The cutting block 200 may be formed from anysuitable material. For example, the cutting block 200 may be formed froma material such as a plastic or resin material. In one particularembodiment, the cutting block 200 is formed from Vero resin using arapid prototype fabrication process. However, the cutting block 200 maybe formed from other materials in other embodiments. For example, inanother particular embodiment, the cutting block 200 is formed from apolyimide thermoplastic resin, such as a Ultem resin, which iscommercially available from Saudi Basic Industries CorporationInnovative Plastics of Riyhadh, Saudi Arabia.

The body 202 includes a bone-contacting or bone-facing surface 212 andan outer surface 214 opposite the bone-facing surface 212. The outersurface 214 includes a number of guide holes or passageways 216 definedtherethrough. A guide pin bushing 218 is received in each guide hole216. The guide pin bushings 218 include an internal passageway 220 sizedto receive a respective guide pin to secure the block 200 to thepatient's femur. As shown in FIG. 12, the guide passageways 216 extendsfrom the outer surface 214 to the bone-facing surface 212 and iscounterbored on the bone-facing surface 212. That is, the passageway 216has an opening 222 on the bone-facing surface 212 having a diametergreater than the diameter of an opening 224 on the outer surface 214

The cutting block 200 includes a cutting guide 230 secured to the body202. In one particular embodiment, the cutting guide 230 is overmoldedto the body 202. The cutting guide 230 includes a cutting guide slot232. The cutting guide 230 may be formed from the same material as thebody 202 or from a different material. In one particular embodiment, thecutting guide 230 is formed from a metallic material such as stainlesssteel. The body 202 also includes a window or opening 234 definedtherethough. The opening 234 allows a surgeon to visualize thepositioning of the block 200 on the patient's femur by viewing portionsof the femur through the opening 234. Additionally, the opening 234 mayreduce the amount of air pockets or other perfections created during thefabrication of the block 200. In the illustrative embodiment, theopening 234 extends from the cutting guide 200 to a point more superiorthan the superior-most point 236 of the guide pin bushings 218. However,in other embodiments, the cutting block 200 may include windows oropenings formed in the body 202 having other shapes and sizes.

The bone-facing surface 212 of the body 202 includes a negative contour238 configured to receive a portion of the anterior side of thepatient's femur having a corresponding contour. As discussed above, thecustomized patient-specific negative contour 238 of the bone-contactingsurface 212 allows the positioning of the cutting block 200 on thepatient's femur in a unique pre-determined location and orientation.

The tabs 204, 206 include a bone-contacting or bone-facing surface 240,242, respectively, and an outer surface 244, 246, respectively, oppositethe bone-facing surface 240, 242. The bone-facing surface 240 of the tab204 includes a negative contour 248 configured to receive a portion ofthe distal side of the patient's femur having a respective correspondingcontour. Similarly, the bone-facing surface 242 of the tab 206 includesa negative contour 250 configured to receive a portion of the distalside of the patient's femur having a respective corresponding contour.

As discussed above, the arms or tabs 204, 206 extend posteriorly fromthe body 200 to define a U-shaped opening 205 therebetween. The tabs204, 206 may extend from the body 202 the same distance or a differentdistance. For example, as shown in FIG. 11, the tab 204 extends from thebody 202 a distance 252 and the tab 206 extends from the body 202 adistance 254, which is less than the distance 252. Each of the tabs 204,206 includes a respective guide hole or passageway 260 definedtherethrough. A guide pin bushing 262 is received in each guide hole260. The guide pin bushings 262 include an internal passageway 264 sizedto receive a respective guide pin to further secure the block 200 to thepatient's femur. Similar to the guide passageways 216, the guidepassageways 260 may be counterbored on the bone-facing surface 240, 242of the tabs 204, 206.

The lips 208, 210 of the tabs 204, 206 also include a bone-contacting orbone-facing surface 272, 274, respectively, and an outer surface 276,278, respectively, opposite the bone-facing surface 272, 274. Thebone-facing surface 272 of the lip 208 includes a negative contour 280configured to receive a portion of the posterior side of the patient'sfemur having a respective corresponding contour. Similarly, thebone-facing surface 274 of the lip 210 includes a negative contour 282configured to receive a portion of the posterior side of the patient'sfemur having a respective corresponding contour. Each the lips 208, 210include a lateral slot 284 that forms a saw relief slot and isconfigured to provide an amount of clearance for the bone saw blade usedto remove a portion of the patient's bone. That is, during theperformance of the orthopaedic surgical procedure, a distal end of thebone saw blade may be received in the slot 284.

In addition, in some embodiments, the negative contours 238, 248, 250,280, 282 of the bone-contacting surfaces 212, 240, 242, 272, 274 of thecutting block 200 may or may not match the remaining correspondingcontour surface of the patient's bone. That is, as discussed above, thenegative contours 238, 248, 250, 280, 282 may be scaled or otherwiseresized (e.g., enlarged) to compensate for the patient's cartilage orlack thereof.

As shown in FIG. 16, the femoral cutting block 200 is fabricated basedon a surgical design plan that includes, amongst many other things, adetermination of the size of the bone chips that will be created when asurgeon resects the patient's femur with the cutting block 200. Forexample, the design plan used to fabricate the femoral cutting block 200includes a preoperatively determined size of a distal medial bone chipproduced as a result of a surgical resection of the distal medialportion of the patient's distal femur (DMF) with the cutting block 200.It also includes the planned size of a distal lateral bone chip producedas a result of a surgical resection of the distal lateral portion of thepatient's distal femur (DLF) with the cutting block 200. The surgicaldesign plan used to fabricate the customized patient-specific femoralcutting block 200 also includes the size of a posterior medial bone chipproduced as a result of a surgical resection of the posterior medialportion of the patient's distal femur (PMF) by use of the cutting block200, and a posterior lateral bone chip produced as a result of asurgical resection of the posterior lateral portion of the patient'sdistal femur (PLF).

Indicia indicative of the size of each preoperatively planned size ofthe bone chip is applied to an outer surface of the cutting block. Forexample, indicia 292 indicative of the preoperatively planned size of adistal medial bone chip produced as a result of a surgical resection ofthe distal medial portion of the patient's distal femur (DMF) with thecutting block 200 is applied to one of the outer medial surfaces of thebody 202 of the cutting block 200. Indicia 292 indicative of thepreoperatively planned size of a distal medial bone chip produced as aresult of a surgical resection of the distal lateral portion of thepatient's distal femur (DLF) with the cutting block 200 is applied toone of the outer lateral surfaces of the body 202 of the cutting block200. Indicia 292 indicative of the preoperatively planned size of aposterior medial bone chip produced as a result of a surgical resectionof the posterior medial portion of the patient's distal femur (PMF) withthe cutting block 200 is applied to one of the outer medial or anteriorsurfaces of the body 202 of the cutting block 200. Indicia 292indicative of the preoperatively planned size of a posterior lateralbone chip produced as a result of a surgical resection of the posteriorlateral portion of the patient's distal femur (PLF) with the cuttingblock 200 is applied to one of the outer medial or anterior surfaces ofthe body 202 of the cutting block 200. It should be appreciated that theindicia may be applied to the body 202 of the cutting block 200 in anumber of different manners. For example, the indicia 292 may be etched,painted, engraved, etcetera onto the body 202 of the cutting block 200.

In use, the femoral cutting block 200 is coupled to the distal end ofthe patient's femur. Again, because the bone-contacting surfaces 212,240, 242, 272, 274 of the cutting block 200 include the negativecontours 238, 248, 250, 280, 282, the block 200 may be coupled to thepatient's femur in a pre-planned, unique position. When so coupled, thetabs 204, 206 wrap around the distal end of the patient's femur and thelips 208, 210 of the tabs 204, 206 wrap around the posterior side of thepatient's femur. Additionally, when the block 200 is coupled to thepatient's femur, a portion of the anterior side of the femur is receivedin the negative contour 238 of the body 202, a portion of the distalside of the patient's femur is received in the negative contours 248,250 of the tabs 204, 206, and a portion of the posterior side of thefemur is received in the negative contours 280, 282 of the lips 208,210. As such, the anterior, distal, and posterior surfaces of thepatient femur are referenced by the femoral cutting block 200.

Once secured to the distal end of the patient's femur, the cutting block200 is used to resect the patient's bone along the preoperativelyplanned cutting planes. In doing so, the surgeon produces a distalmedial bone chip as a result of resection of the distal medial portionof the patient's distal femur (DMF), and a distal lateral bone chip as aresult of resection of the distal lateral portion of the patient'sdistal femur (DLF). The surgeon also produces a posterior medial bonechip as a result of a surgical resection of the posterior medial portionof the patient's distal femur (PMF), and a posterior lateral bone chipas a result of resection of the posterior lateral portion of thepatient's distal femur (PLF). In lieu of simply disregarding orotherwise disposing the bone chips, they are used to validate thesurgeon's performance of the surgery in conformance with thepreoperative surgical plan. In particular, since the surgeon is aware ofthe preoperatively determined size of each of the bone chips that areproduced if the bone is resected along the preoperatively plannedcutting planes, the surgeon can simply measure the actual bone chipscreated in the surgery and compare them to the preoperatively plannedsizes. For example, if a proper resection of the distal medial portionof the patient's distal femur (DMF) according to the preoperative planshould produce a 7.5 mm distal medial bone chip, the surgeon can measurethe actual distal medial bone chip produced in the surgery with, forexample, a pair of calipers to determine if the chip is, in fact, 7.5mm. Confirmation of the size of the bone chip is used, therefore, theconfirm a proper cut has been made. The surgeon may confirm all fourbone chips made during surgical preparation of the patient's femur. Ifneed be, the femur can then be re-cut to remove more bone.

Referring now to FIGS. 13-15, in another embodiment, the customizedpatient-specific orthopaedic surgical instrument may be embodied as atibial cutting block 300. The cutting block 300 is configured to becoupled to a tibia of a patient. The cutting block 300 includes a body302 configured to be coupled to the anterior side of the patient's tibiaand two arms or tabs 304, 306, which extend away from the body 302 in aposteriorly direction. The tabs 304, 306 are configured to wrap over aproximal end of the tibia as discussed in more detail below. The cuttingblock 300 may be formed from any suitable material. For example, thecutting block 300 may be formed from a material such as a plastic orresin material. In one particular embodiment, the cutting block 300 isformed from Vero resin using a rapid prototype fabrication process.However, the cutting block 300 may be formed from other materials inother embodiments. For example, in another particular embodiment, thecutting block 300 is formed from a polyimide thermoplastic resin, suchas a Ultem resin, which is commercially available from Saudi BasicIndustries Corporation Innovative Plastics of Riyhadh, Saudi Arabia.

The body 302 includes a bone-contacting or bone-facing surface 312 andan outer surface 314 opposite the bone-facing surface 312. The outersurface 314 includes a depression or recessed area 316, which providesan indication to a surgeon where to apply pressure to the body 302 whencoupling the cutting block 300 to the patient's tibia. Additionally, anumber of guide pin holes or passageways 318 are defined through thebody 302 and have a diameter sized to receive respective guide pins tosecure the block 300 to the patient's tibia. In some embodiments, one ormore of the guide pin holes 318 may be oblique or otherwise angled withrespect to the remaining guide pin holes 318 to further secure the block300 to the patient's bone.

The body 302 includes a modular cutting guide 320. That is, the body 302includes a cutting guide receiver slot 322 in which the cutting guide320 is received. A latch 324 or other locking device secures the cuttingguide 320 in place in the cutting guide receiver slot 322. As such, oneof a number of different cutting guides 320 having a cutting guide slot326 defined in various offset positions may be coupled to the body 302to allow a surgeon to selectively determine the amount of bone of thepatient's bone is removed during the bone cutting procedure. Forexample, a cutting guide 320 having a cutting guide slot 326 offset by+2 millimeters, with respect to a neutral reference cutting guide 320,may be used if the surgeon desires to remove a greater amount of thepatient's bone. The cutting guide 320 may be formed from the samematerial as the body 302 or from a different material. In one particularembodiment, the cutting guide 320 is formed form a metallic materialsuch as stainless steel. It should be appreciated that the cutting block300 may be embodied without a modular cutting guide 320. That is, thecutting block 300 may be embodied with a fixed cutting guide 320 that isovermolded into the polymer body 302

The bone-facing surface 312 of the body 302 includes a negative contour328 configured to receive a portion of the anterior side of thepatient's tibia having a corresponding contour. As discussed above, thecustomized patient-specific negative contour 328 of the bone-contactingsurface 312 allows the positioning of the cutting block 300 on thepatient's tibia in a unique pre-determined location and orientation.

As discussed above, the arms or tabs 304, 306 extend posteriorly fromthe body 302 to define a U-shaped opening 305 therebetween. The tabs304, 306 may extend from the body 302 the same distance or a differentdistance. For example, as shown in FIG. 14, the tab 304 extends from thebody 302 a distance 330 and the tab 306 extends from the body 302 adistance 332, which is greater than the distance 330. The tabs 304, 306taper in the anterior-posterior direction. That is, the thickness of thetabs 304, 306 at an anterior end of the tabs 304, 306 is greater thanthe thickness of the tabs 304, 306 at a respective posterior end 307,309. The tapering of the tabs 304, 306 allow the tabs 304, 306 to beinserted within the joint gap defined between the patient's femur andtibia.

The tabs 304, 306 include a bone-contacting or bone-facing surface 340,342, respectively, and an outer surface 344, 346, respectively, oppositethe bone-facing surface 340, 342. The bone-facing surface 340 of the tab304 includes a negative contour 348 configured to receive a portion ofthe patient's proximal tibia having a respective corresponding contour.Similarly, the bone-facing surface 342 of the tab 306 includes anegative contour 350 configured to receive a portion of the patient'sproximal tibia having a respective corresponding contour.

In addition, in some embodiments, the negative contours 328, 348, 350 ofthe bone-contacting surfaces 312, 340, 342 of the cutting block 300 mayor may not match the remaining corresponding contour surface of thepatient's bone. That is, as discussed above, the negative contours 328,348, 350 may be scaled or otherwise resized (e.g., enlarged) tocompensate for the patient's cartilage or lack thereof.

As shown in FIG. 16, the tibial cutting block 300 is fabricated based ona surgical design plan that includes, amongst many other things, adetermination of the size of the bone chips that will be created when asurgeon resects the patient's tibia with the cutting block 300. Forexample, the design plan used to fabricate the tibial cutting block 300includes the preoperatively determined size of the bone chip (or chips)produced as a result of a surgical resection of the proximal medialportion (MT) and the proximal lateral portion (LT) of the patient'sproximal tibia with the cutting block 300. Indicia indicative of thesize of such preoperatively planned bone chip(s) is applied to an outersurface of the cutting block 300. For example, indicia 390 indicative ofthe preoperatively planned size of a bone chip produced as a result of asurgical resection of the proximal medial portion (MT) and the proximallateral portion (LT) of the patient's proximal tibia with the cuttingblock 300 is applied to one of the outer anterior surfaces of the body302 of the cutting block 300. It should be appreciated that the indiciamay be applied to the body 302 of the cutting block 300 in a number ofdifferent manners. For example, the indicia 390 may be etched, painted,engraved, etcetera onto the body 302 of the cutting block 300.

In use, the tibial cutting block 300 is coupled to the proximal end ofthe patient's tibia. Again, because the bone-contacting surfaces 312,340, 342 of the cutting block 300 include the negative contours 328,348, 350, the block 300 may be coupled to the patient's tibia in apre-planned, unique position. When so coupled, the tabs 304, 306 wraparound the proximal end of the patient's tibia. Additionally, when theblock 300 is coupled to the patient's tibia, a portion of the anteriorside of the tibia is received in the negative contour 328 of the body302 and a portion of the proximal side of the patient's tibia isreceived in the negative contours 348, 350 of the tabs 304, 306. Assuch, the anterior and proximal surfaces of the patient tibia arereferenced by the tibial cutting block 300.

Once secured to the distal end of the patient's tibia, the cutting block300 is used to resect the patient's bone along the preoperativelyplanned cutting planes. In doing so, the surgeon produces a bone chip(or chips) as a result of a surgical resection of the proximal medialportion (MT) and the proximal lateral portion (LT) of the patient'sproximal tibia. In lieu of simply disregarding or otherwise disposingthe bone chip(s), it is used to validate the surgeon's performance ofthe surgery in conformance with the preoperative surgical plan. Inparticular, since the surgeon is aware of the preoperatively determinedsize of the bone chip(s) produced if the tibia is resected along thepreoperatively planned cutting plane(s), the surgeon can simply measurethe actual bone chip(s) created in the surgery and compare it to thepreoperatively planned size. For example, if a proper resection of theof the proximal medial portion (MT) and the proximal lateral portion(LT) of the patient's proximal tibia should produce a bone chip that is3.0 mm thick on the proximal medial side (MT) and 10.0 mm thick on theproximal lateral side (LT), the surgeon can measure the actual bone chipproduced in the surgery with, for example, a pair of calipers todetermine if the chip is, in fact, 3.0 mm thick on the proximal medialside (MT) and 10.0 mm thick on the proximal lateral side (LT).Confirmation of the size of the bone chip is used, therefore, theconfirm a proper cut has been made. If need be, the tibia can then bere-cut to remove more bone.

It should be appreciated that certain aspects of the methods describedherein may be utilized without the use of customized patient-specificinstruments. For example, a surgical design plan can be preoperativelydesigned in the manner described herein, including a determination ofthe sizes of the various bone chips that are to be created if aresection of the patient's bone is performed according to the plan.However, the plan may contemplate that the actual resection will beperformed with standard instruments (i.e., instruments that are notcustomized for a particular patient). In such a case, the surgicaldesign plan alone is the output from the preoperative design process.The plan may be transmitted to the surgeon via a printed document orelectronic file, and, like the other plans described herein, may includeelectronic and/or visual representations of the plan's various features.

Like the process described above utilizing customized patient-specificinstruments, the surgeon may use information from the preoperativelydesigned surgical plan even though customized instruments are not beingused. For example, the surgeon can utilize the preoperatively plannedcutting planes to perform the cuts on the patient's bone. Moreover, thesurgeon can save and thereafter measure the resultant bone chips toconfirm the surgeon's conformance with the plan.

While the disclosure has been illustrated and described in detail in thedrawings and foregoing description, such an illustration and descriptionis to be considered as exemplary and not restrictive in character, itbeing understood that only illustrative embodiments have been shown anddescribed and that all changes and modifications that come within thespirit of the disclosure are desired to be protected.

There are a plurality of advantages of the present disclosure arisingfrom the various features of the apparatus, system, and method describedherein. It will be noted that alternative embodiments of the apparatus,system, and method of the present disclosure may not include all of thefeatures described yet still benefit from at least some of theadvantages of such features. Those of ordinary skill in the art mayreadily devise their own implementations of the apparatus, system, andmethod that incorporate one or more of the features of the presentinvention and fall within the spirit and scope of the present disclosureas defined by the appended claims.

1. A method for a vendor to create a customized patient-specificorthopaedic instrument for a patient of a healthcare facility that isexternal to the vendor, comprising: receiving, from the healthcarefacility external to the vendor, an instrument request that includesdata relevant to a bone of the patient, creating, in response toreceiving the instrument request, a surgical design plan that has beencustomized for the patient per data of the instrument request, thesurgical design plan comprising a preoperatively planned size of atleast one bone chip produced as a result of a surgical resection of thebone of the patient consistent with the surgical design plan, andsending the surgical design plan to the healthcare facility.
 2. Themethod of claim 1, further comprising: operating a manufacturing machinelocated at the vendor to fabricate the customized patient-specificorthopaedic instrument per data of the surgical design plan, and sendingthe fabricated customized patient-specific orthopaedic instrument to thehealthcare facility.
 3. The method of claim 11, wherein sending thesurgical design plan comprises transmitting the surgical design plan tothe healthcare facility via a network.
 4. The method of claim 1, whereinsending the design plan comprises mailing the surgical design plan tothe healthcare facility.
 5. The method of claim 1, wherein: the datarelevant to the bone of the patient comprises one or more medical imagesof the bone of the patient, and creating the surgical design plancomprises creating the surgical design plan based upon the one or moremedical images of the bone of the patient.
 6. The method of claim 1,wherein: the data relevant to the bone of the patient comprises one ormore medical images of the femur of the patient, and creating thesurgical design plan comprises creating a surgical design plan thatcomprises a preoperatively planned size of (i) a distal medial bone chipproduced as a result of a surgical resection of the distal medialportion of the patient's distal femur consistent with the surgicaldesign plan, and (ii) a distal lateral bone chip produced as a result ofa surgical resection of the distal lateral portion of the patient'sdistal femur consistent with the surgical design plan.
 7. The method ofclaim 6, wherein creating the surgical design plan further comprisescreating a surgical design plan that comprises a preoperatively plannedsize of (i) a posterior medial bone chip produced as a result of asurgical resection of the posterior medial portion of the patient'sdistal femur consistent with the surgical design plan, and (ii) aposterior lateral bone chip produced as a result of a surgical resectionof the posterior lateral portion of the patient's distal femurconsistent with the surgical design plan.
 8. The method of claim 1,wherein: the data relevant to the bone of the patient comprises one ormore medical images of the tibia of the patient, and creating thesurgical design plan comprises creating a surgical design plan thatcomprises a preoperatively planned size of a bone chip produced as aresult of a surgical resection of the proximal medial portion and theproximal lateral portion of the patient's proximal tibia consistent withthe surgical design plan.
 9. The method of claim 1, wherein creating thesurgical design plan comprises creating a surgical design plan thatcomprises a visual indication of the bone chip produced as a result ofthe surgical resection of the bone of the patient consistent with thesurgical design plan.
 10. A method of performing an orthopaedic surgicalprocedure on a bone of a patient at a healthcare facility, comprising:making a cut in the bone of the patient at a location indicated in asurgical design plan obtained from a vendor that is external to thehealthcare facility that has been customized for the patient per datarelevant to a bone of the patient, the surgical design plan comprising apreoperatively planned size of a bone chip produced as a result of thecut, measuring the actual size of the bone chip produced as a result ofthe cut, and comparing the measured actual size of the bone chip to thepreoperatively planned size of the bone chip of the surgical designplan.
 11. The method of claim 10, wherein making the cut comprisesmaking the cut with a customized patient-specific orthopaedic cuttingblock fabricated per data of the surgical design plan.
 12. The method ofclaim 10, wherein making the cut on the bone of the patient comprisesmaking a cut in the bone of the patient at a location indicated in asurgical design plan obtained from a vendor that is external to thehealthcare facility that has been customized for the patient per one ormore medical images of the bone of the patient.
 13. The method of claim10, wherein: the surgical design plan comprises a preoperatively plannedsize of (i) a distal medial bone chip produced as a result of a surgicalresection of the distal medial portion of the patient's distal femurconsistent with the surgical design plan, and (ii) a distal lateral bonechip produced as a result of a surgical resection of the distal lateralportion of the patient's distal femur consistent with the surgicaldesign plan, making the cut comprises (i) resecting the distal medialportion of the patient's distal femur to produce a distal medial bonechip, and (ii) resecting the distal lateral portion of the patient'sdistal femur to produce a distal lateral bone chip, measuring the actualsize of the bone chip comprises measuring the actual size of the distalmedial bone chip and the distal lateral bone chip, and comparing themeasured actual size of the bone chip comprises (i) comparing themeasured actual size of the distal medial bone chip to thepreoperatively planned size of the distal medial bone chip of thesurgical design plan, and (ii) comparing the measured actual size of thedistal lateral bone chip to the preoperatively planned size of thedistal lateral bone chip of the surgical design plan.
 14. The method ofclaim 13, wherein: the surgical design plan further comprises apredetermined size of (i) a posterior medial bone chip produced as aresult of a surgical resection of the posterior medial portion of thepatient's distal femur consistent with the surgical design plan, and(ii) a posterior lateral bone chip produced as a result of a surgicalresection of the posterior lateral portion of the patient's distal femurconsistent with the surgical design plan, making the cut furthercomprises (i) resecting the posterior medial portion of the patient'sdistal femur to produce a posterior medial bone chip, and (ii) resectingthe posterior lateral portion of the patient's distal femur to produce aposterior lateral bone chip, measuring the actual size of the bone chipfurther comprises measuring the actual size of the posterior medial bonechip and the posterior lateral bone chip, and comparing the measuredactual size of the bone chip further comprises (i) comparing themeasured actual size of the posterior medial bone chip to thepreoperatively planned size of the posterior medial bone chip of thesurgical design plan, and (ii) comparing the measured actual size of theposterior lateral bone chip to the preoperatively planned size of theposterior lateral bone chip of the surgical design plan.
 15. The methodof claim 10, wherein: the surgical design plan comprises apreoperatively planned size of a bone chip produced as a result of asurgical resection of the proximal medial portion and the proximallateral portion of the patient's proximal tibia consistent with thesurgical design plan, and making the cut comprises resecting theproximal medial portion and the proximal lateral portion of thepatient's proximal tibia to produce a bone chip.
 16. The method of claim10, wherein measuring the actual size of the bone chip comprisesmeasuring the actual size of the bone chip with calipers.
 17. A methodof performing an orthopaedic surgical procedure on a bone of a patient,comprising: preoperatively planning a size of a bone chip to be producedby resecting the bone of the patient at a predetermined location, makinga cut in the bone of the patient at the predetermined location therebyproducing a bone chip, measuring the actual size of the bone chipproduced as a result of the cut, and comparing the measured actual sizeof the bone chip to the preoperatively planned size of the bone chip.18. The method of claim 17, further comprising re-cutting the bone ofthe patient if the measured actual size of the bone chip is smaller thanthe preoperatively planned size of the bone chip.
 19. The method ofclaim 10, wherein measuring the actual size of the bone chip comprisesmeasuring the actual size of the bone chip with calipers.